Multifunction surgical device

ABSTRACT

A surgical device is disclosed along with methods of using the same. The surgical device may comprise an outer sheath and a collar assembly. The collar assembly may be coupled to the outer sheath and may comprise a first arm coupled to the outer sheath at a first hinge; a second arm coupled to the first arm at a second hinge; and a collar coupled to the second arm. The collar assembly may be movable from an un-deployed position where the first arm and the second arm extend the collar distally from the outer sheath to a deployed position where the collar is aligned with the first channel of the outer sheath. Also, the first arm, the second arm, and the collar may be positioned substantially within a cross-sectional area of a distal end of the outer sheath when the collar assembly is in the un-deployed position.

BACKGROUND

Various embodiments are directed to multifunctional surgical devices andmethods of using the same.

In endoscopic, laparoscopic, and other noninvasive surgical techniques,internal suturing or other tissue fastening must be performed withinstruments small enough to fit through a trocar or endoscope workingchannel, which can often be quite narrow. For example, the workingchannel of a typical flexible endoscope has a diameter in the range ofabout 2.5 to about 4 millimeters. Current staplers and suturing devicescannot be easily redesigned to work through such small openings. Inaddition, performing procedures by way of the working channel does noteasily permit using two instruments positioned at different angles withrespect to the wound site in order to “pass and catch” a needle andapply sutures.

Various clips, suture fasteners and anchors have been developed suchthat clinicians may endoscopically close tissue perforations resultingfrom, for example, ulcers, polypectomy, incisions, etc. One type ofsuture anchor is known as a “T-tag” fastener. The T-tag is a smallmetallic pin with a suture attached at the middle. The physician mayload the T-tag into the end of a cannulated needle of an applicator thatmay be inserted through the working channel of an endoscope. Thephysician may push the needle into the tissue near the perforation andimplant the T-tag into the tissue with the attached suture trailingthrough the working channel and out the proximal end of the endoscope.After two or more T-tags are attached to the tissue near the wound inthis manner, the physician may pull the sutures to appose the tissuearound the wound. The physician may then fasten the sutures together byapplying a plurality of alternating, right and left overhand knots usinga knot pushing device or by applying a knotting element or other type offastener through the working channel of the endoscope.

FIGS. 1-5 illustrate an example procedure for repairing a wound, such asa gastric bleeding ulcer in the stomach wall of the patient, through aworking channel of an endoscope. FIG. 1 illustrates a flexibleendoscopic portion 16 of a gastroscope 14 inserted into the uppergastrointestinal tract of a patient. As shown in FIG. 2, the clinician(e.g., gastroenterologist) inserts a suture anchor applicator 18 throughthe gastroscope 14 and penetrates a cannulated needle 19 through thestomach wall near the diseased area or wound. The needle 19 contains atleast one suture anchor such that, as shown in FIG. 3, the physician maydeploy a first suture anchor 20 attached to a first suture 24 to oneside of the wound and a second suture anchor 22 attached to a secondsuture 26 to the opposite side of the wound. The free ends of the firstand second sutures 24, 26 may extend through the proximal end of thegastroscope 14 such that, as shown in FIG. 4, the physician may draw thefirst and second sutures 24, 26 together to appose the tissue around thewound. The physician may then fasten the first and second sutures 24, 26together by knotting them, or using a knotting element or fastener. FIG.5 illustrates an example knotting element 28 applied to sutures 24, 26.Excess suture may be trimmed near the knot using an endoscopic cuttinginstrument.

An issue typically associated with current suture anchor applicators,such as those described in FIGS. 1-5, is the risk that nearby organs maybe accidentally injured by the needle 19 of the applicator. Thephysician normally cannot see anatomical structures on the distal sideof the tissue layers when the needle is being pushed through the tissuelayers. Therefore, there is a risk that adjacent organs may beaccidentally injured by the penetrating needle.

FIGURES

The novel features of the various embodiments are set forth withparticularity in the appended claims. The various embodiments, however,both as to organization and methods of operation, together withadvantages thereof, may best be understood by reference to the followingdescription, taken in conjunction with the accompanying drawings asfollows.

FIG. 1 is a drawing of one embodiment of a flexible, endoscopic portionof a gastroscope inserted into the upper gastrointestinal tract of apatient.

FIG. 2 is a drawing of the distal portion of one embodiment of a sutureanchor applicator extending from the distal end of the gastroscope whilea first suture anchor is deployed into the stomach wall near a wound.

FIG. 3 is a drawing of one embodiment of the applicator of FIG. 2 whilea second suture anchor is deployed into the stomach wall on the opposingside of the wound.

FIG. 4 is a drawing of one embodiment of the applicator of FIG. 2 whilea pair of sutures of the first and second suture anchors are drawntogether to appose the tissue on each side of the wound.

FIG. 5 is a drawing of the pair of sutures of FIG. 4 fastened togetherwith a knotting element, thereby holding the tissue in apposition.

FIG. 6 illustrates one embodiment of a distal end effector of a surgicaldevice.

FIG. 7 illustrates one embodiment of the end effector of FIG. 6 with thecollar assembly in the un-deployed position.

FIG. 8 illustrates one embodiment of an end effector with awire-operated collar assembly.

FIG. 9 illustrates one embodiment of the end effector of FIG. 8 with thecollar assembly in the deployed position.

FIG. 10 illustrates an alternative view of the end effector of FIG. 8with the collar assembly in the deployed position showing the wires andthe channel.

FIG. 11 illustrates one embodiment of an end effector with an alternatecollar.

FIGS. 12A and 12B illustrate one embodiment of the end effector of FIG.6 being used to suture tissue.

FIGS. 13A, 13B, and 13C illustrate an alternate method of suturingtissue using the end effector of FIG. 6.

FIGS. 14A, 14B and 14C illustrate another alternate method of suturingtissue using the end effector of FIG. 8.

FIGS. 15A and 15B illustrates one embodiment of the end effector of FIG.6 being used to create a continuous stitch.

FIGS. 16A and 16B illustrate another embodiment of the end effector ofFIG. 6 being used to create a continuous stitch.

FIG. 17 illustrates one embodiment of an end effector configured toperform bipolar procedures, such as electrocoagulation.

DESCRIPTION

FIG. 6 illustrates one embodiment of a surgical end effector 100. Theend effector 100 may comprise an outer sheath 102, a suture applicator,such as a needle 106, and a collar assembly 104. The outer sheath 102may extend proximally to a handle (not shown) of the surgicalinstrument. The needle 106 may be positioned within a channel 108 of theouter sheath 102 and may be extended distally to apply suture and/orsuturing anchors to tissue. Although various embodiments are describedwith a suture applicator needle 106, it will be appreciated that variousother suture applicator devices may be substituted.

The collar assembly 104 may perform various functions during suturing.For example, a hollow collar 114 of the collar assembly 104 may bedeployed distally in line with the needle 106 as shown. The collar 114may be positioned relative to the needle 106 on the opposite side oftissue to be sutured. When the needle 106 is extended distally throughthe tissue, the collar 114 may provide a counter force orcounter-traction on the opposite side of the tissue. Thiscounter-traction may make it easier for the needle 106 to penetrate thetissue. In various embodiments, the collar 114 may define a cavity 118having a cap 120, which may arrest distal movement of the needle 106 andprevent it from extending too far and injuring surrounding organs andtissue. Also, according to various embodiments, the collar assembly 104may be used to grasp and/or position tissue before the needle 106 isextended.

The end effector 100 may be utilized with any suitable surgical devicetype and may be introduced to a surgical site according to any suitablemethod. For example, the end effector 100 may be utilized in atraditional open surgical environment, or may be introduced via a trocarin a laparoscopic surgical environment or via a working channel of anendoscope in an endoscopic surgical environment. According to variousembodiments, the end effector 100 may be introduced via natural orificesand may be combined with trans-organ techniques. In one embodiment,Natural Orifice Translumenal Endoscopic Surgery (NOTES)™ techniques maybe employed to introduce instruments into the patient and carry out thevarious procedures described hereinbelow. A NOTES™ technique is aminimally invasive therapeutic procedure that may be employed to treatdiseased tissue or perform other therapeutic operations through anatural opening of the patient without making incisions in the abdomen.A natural opening may be the mouth, anus, and/or vagina. Medicalimplantable instruments may be introduced into the patient to the targetarea via the natural opening. In a NOTES™ technique, a surgeon inserts aflexible endoscope into one or more natural openings of the patient toview the target area using a camera. During endoscopic surgery, thesurgeon inserts surgical devices through one or more lumens or workingchannels of the endoscope to perform various key surgical activities(KSA). These KSAs include forming an anastomosis between organs,repairing ulcers and other wounds, etc.

Referring again to FIG. 6, the collar assembly 104 may comprise an innerarm 110, an outer arm 112 and the collar 114. The inner arm 110 may becoupled to the outer sheath 102 at a hinge 116. The inner arm 110 mayalso be coupled to the outer arm 112 at a hinge 122. The collar 114 maybe coupled to the outer arm 112 according to any suitable method (e.g.,adhesive, welding, fasteners, etc.). According to various embodiments,the outer arm 112 and the collar 114 may be formed from a single pieceof material.

The collar assembly 104 may be oriented in a deployed position, asillustrated in FIG. 6, or an un-deployed position. FIG. 7 illustratesone embodiment of the end effector 100 with the collar assembly 104 inthe un-deployed position. In the un-deployed position, the variouscomponents of the collar assembly 104 may be extended distally to beroughly in line with the outer sheath 102. When the collar assembly 104is in the un-deployed position, its distal cross section may be lessthan when it is in the deployed position. This may allow the endeffector 100 to more easily pass through a trocar or endoscope workingchannel. According to various embodiments, the cross-sectional area ofthe collar assembly 104 may substantially within the cross-sectionalarea of the outer sheath 102 when the collar assembly 104 is in theun-deployed position. Once the end effector 100 has passed through thetrocar or endoscope working channel, the collar assembly 104 may betransitioned to the deployed position for use.

The collar assembly 104 may be transitioned between the deployed andun-deployed positions according to any suitable method. For example, asshown in FIGS. 1 and 2, the collar assembly 104 may comprise a springrod 124 coupled between the outer arm 112 and the inner arm 110. Thespring rod 124 may exert a force tending to bias the collar assembly 104to the deployed position illustrated in FIG. 6. To introduce the endeffector 100 to a surgical site, the clinician, manually or otherwise,may hold the collar assembly 104 in the un-deployed position illustratedin FIG. 7 and place it in a proximal end of a trocar or endoscopeworking channel. When the end effector 100 emerges from a distal end ofthe trocar or endoscope working channel, the spring rod 124 may bias thecollar assembly 104 back to the deployed position.

FIG. 8 illustrates one embodiment of an end effector 100′ with awire-operated collar assembly 104′. Like the end effector 100, the endeffector 100′ may comprise an outer sheath 102′, a suture applicatorneedle 106′ (not shown in FIG. 8) and the collar assembly 104′. Thecollar assembly 104′ of the end effector 100′, however, may bewire-operated. A spring rod 802 may be coupled to the outer arm 112 andthe inner arm 110. Unlike the spring rod 124, the spring rod 802 mayexert a force on the outer and inner arms, tending to hold the collarassembly 104′ in the un-deployed position, as shown in FIG. 8. One ormore wires 804 may be coupled to the outer arm 112 at mounts 808. Thewires 804 may also be routed through the inner arm 110′ via holes 810.The wires 804 may then extend proximally to a handle (not shown) of thesurgical instrument via a channel 806 of the outer sheath 102′. When aclinician retracts the wires 804 proximally (e.g., by depressing atrigger or other actuator of the surgical device), the wires may exert aforce on the collar assembly 104′ that opposes the force generated bythe spring rod 802 and causes the collar assembly 104′ to transition tothe deployed position. FIG. 9 illustrates one embodiment of the endeffector 100′ with the collar assembly 104′ in the deployed position.Also, FIG. 10 illustrates an alternative view of the end effector 100′with the collar assembly 104′ in the deployed position, showing thewires 804 and the channel 806.

FIG. 11 illustrates one embodiment of the end effector 100 with analternate collar 114″. The collar 114″ defines a cavity 118″ extendingcompletely therethrough (e.g., no cap 120 may be present). Accordingly,the needle 106 may extend through the collar 114″. The collar 114″ mayprovide counter-traction when placed on the opposite side of tissue tobe sutured and may allow the clinician to grasp tissue, for example, asdescribed herein. The collar 114″ may be used with any of the endeffectors 100, 100′ described herein. Although the collar 114″ isillustrated with the end effector 100, it may also be used with the endeffector 100′.

The end effectors 100 and 100′ may be used, according to variousembodiments, to suture tissue. FIG. 12A illustrates one embodiment ofthe end effector 100 being used to suture tissue 1200. The tissue 1200may have an opening 1202 to be closed by suturing. The opening 1202 maybe an ulcer, incision, polypectomy, or other perforation. In use, theclinician may extend the collar 114 and outer arm 112 through theopening 1202, as shown, with the needle 106 retracted within the channel108. The clinician may then extend the needle 106 into or through thetissue 1200, as shown in FIG. 12B. The collar 114 may providecounter-traction, making it easier for the needle 106 to penetrate thetissue 1200. The needle 106 may serve to place a suture or suture anchor(not shown) either into or through the tissue 1200, for example, asdescribed above. When the needle 106 has been fully extended distally,it may contact the cap 120, which may arrest further extension, althoughembodiments utilizing a collar 114″ lacking a cap 120 may also be used.It will be appreciated that the end effector 100′ may be used in amanner similar to that shown in FIGS. 12A and 12B.

FIGS. 13A, 13B, and 13C illustrate an alternate method of suturingtissue using the end effector 100. In FIG. 13A, the end effector 100 ispositioned above tissue 1300. The tissue 1300 may have an opening 1302,which may be an ulcer, incision, polypectomy, or other perforation.While the needle 106 is retracted, the clinician may utilize the collarassembly 104 to position a portion of the tissue 1300 between the collar114 and a distal end of the outer sheath 102 (e.g., the surfaceincluding the channel 108). FIG. 13B shows the end effector 100 with thetissue 1300 positioned between the collar 114 and the distal end of theouter sheath 102. The clinician may position the tissue 1300 using anysuitable surgical technique. For example, the clinician may place thecollar 114 against the tissue 1300 at a desired location. The clinicianmay then pull the outer sheath 102 proximally. Friction and resistancefrom the tissue 1300 may prevent the collar 114 from moving with theouter sheath 102. Accordingly, the collar 114 and outer arm 112 mayoppose the force of the spring rod 124 and increase the gap between thecollar 114 and the outer sheath 102. The clinician may then maneuver theend effector 100 until a desired portion of tissue 1300 is positionedbetween the collar 114 and the outer sheath 102. Then, the clinician maymove the outer sheath 102 distally, allowing the spring rod 124 to forcethe collar assembly 104 to the deployed position. As a result, thetissue 1300 may be held in position, as shown in FIG. 13B. In someembodiments, and in some surgical situations, the spring rod 124 mayprovide sufficient force to clamp the tissue 1300 between the collar 114and the outer sheath 102. Once the tissue 1300 is positioned, the needle106 may be deployed to place a suture or suture anchor (not shown)either into or through the tissue 1300. Again, when the needle 106 hasbeen fully extended distally, it may contact the cap 120, which mayarrest further extension, although embodiments utilizing a collar 114″lacking a cap 120 may also be used.

FIGS. 14A, 14B and 14C illustrate another alternate method of suturingtissue using the end effector 100′. In FIG. 14A, the end effector 100′is positioned above the tissue 1300. While the needle 106′ is retracted,the clinician may utilize the collar assembly 104′ to position a portionof the tissue 1300 between the collar 114′ and a distal end of the outersheath 102′ as shown in FIG. 14B. To position the tissue, the clinicianmay release tension on wires 804. This may allow the spring rod 802 topush the collar 114′ and the outer sheath 102′ away from one another. Aportion of the tissue 1300 may then be positioned between the collar114′ and the outer sheath 102′ according to any suitable method. Thewire 804 may then be retracted proximally, pulling the collar 114′toward the outer sheath 102′ and clamping the tissue 1300. In variousembodiments, the clinician may exert proximal force on the wire 804sufficient to clamp the tissue between the collar 114′ and the outersheath 102′. Once the tissue 1300 is placed, the needle 106′ may bedeployed through the tissue 1300 to place a suture or suture anchor (notshown) as described above. When the needle 106′ is fully extended, itmay contact the cap 120′. This may arrest further distal movement of theneedle 106′, although embodiments utilizing a collar 114″ lacking a cap120 may also be used.

In FIGS. 13A, 13B and 13C as well as in FIGS. 14A, 14B and 14C, theportion of tissue positioned and/or clamped between the collar 114, 114′and the outer sheath 102, 102′ includes the opening 1302. Thus, thecollar assembly 104, 104′ tends to close the opening 1302 between thecollar 114, 114′ and the outer sheath 102, 102′. It will be appreciatedthat, in various embodiments, tissue not including an opening such asopening 1302 may be clamped by the collar assembly 104, 104′. Forexample, it may be desirable to place sutures or suture anchors adjacentto an opening, or even away from an opening, as the surgical situationdictates.

According to various embodiments, end effectors 100, 100′ utilizing acollar 114″ having a cavity 118″ extending completely therethrough, forexample, as shown in FIG. 11, may be utilized to place a continuousstitch. For example, FIGS. 15A and 15B illustrate one embodiment of theend effector 100 being used to create a continuous stitch. As shown inFIG. 15A, the needle 106 is extended through the tissue 1200 and throughthe cavity 118″ of the collar 114″. Then a suture anchor 1502 connectedto a suture 1504 (FIG. 15B) may be deployed from a distal end of theneedle 106. The suture anchor 1502 may either expand and/or change itsorientation after being deployed from the needle 106. As a result, thesuture anchor 1502 may assume a cross-section too large to be pulledproximally through the collar 114″. Accordingly, the anchor 1502 maybecome lodged on a distal end of the collar 114″, allowing the clinicianto pull the anchor 1502 and suture 1504 proximally by pulling the collar114″ proximally. The end effector 100 may then be removed from thesurgical site, pulling the suture 1504 to the clinician. The suture 1504may then be reloaded into the needle 106 with the anchor 1502 or a newanchor (not shown) allowing the clinician to make another stitch.

FIGS. 16A and 16B illustrate another embodiment of the end effector 100being used to create a continuous stitch. The needle 106 may be extendedthrough tissue 1300 and through the cavity 118″. A suture anchor 1502and suture 1504 (FIG. 16B) may be deployed from the needle 106. Asdescribed above, the suture anchor 1502 may either pivot or expand afterbeing deployed from the needle, making it larger than the cavity 118″.This may cause the suture anchor 1502 to become lodged against thecollar 114″, allowing the clinician to remove the suture anchor 1502 andsuture 1504 from the surgical site with the collar 114″. As describedabove, the suture 1504 may then be re-loaded into the needle 106 andadvanced to the surgical site to make another stitch. Although FIGS.15A, 15B, 16A, and 16B are illustrated with the end effector 100, itwill be appreciated that the end effector 100′ may be substituted andused in a similar manner.

According to various embodiments, the various end effectors 100, 100′may be used to perform surgical tasks other than suturing including, forexample, grasping, punch biopsy, electrocoagulation, bipolarelectrocoagulation, etc. Any suitable method may be utilized. Forexample, a clinician may grasp tissue using one of the techniquesillustrated in FIGS. 12A-B, FIGS. 13A-C and/or FIGS. 14A-C withoutextending the needle 106. Some embodiments of the end effectors 100,100′ may be specifically designed for non-suturing tasks and may omitthe needle 106.

FIG. 17 illustrates one embodiment of an end effector 100′″ configuredto perform bipolar procedures, such as electrocoagulation. The collar114′″ may comprise a first electrode 1702. A second electrode 1704 maybe positioned on the inner arm 110′″, or may be positioned on the outersheath 102′″. When the end effector 100′″ is in the deployed position,the electrodes 1702, 1704 may be positioned approximately opposite oneanother. The electrodes 1702, 1704 may be in electrical communicationwith a power source (not shown), which, for example, may be located awayfrom the surgical site. In use, the clinician may position tissuebetween the electrodes 1702, 1704, for example, similar to the way thattissue was positioned for suturing in the embodiments described above.When tissue is positioned between the electrodes 1702, 1704, theclinician may activate the power source, which energizes the electrodescausing the tissue to be electrocoagulated, or otherwise electricallyacted upon. Some embodiments of the end effector 100′″ may also includea needle (not shown) or other suturing applicator that may be used asdescribed above.

The electrodes 1702, 1704 may be placed in electrical communication withthe power source according to any suitable methods. For example,electrical wires (not shown) may extend proximally from the electrodes1702, 1704 through the outer sheath 102′″ to the power source. In someembodiments, the outer arm 112′″ and/or the inner arm 110′″ may compriselumens for receiving the electrical wires. Also, it will be appreciatedthat the electrodes 1702, 1704 may be electrically isolated from eachother. For example, the inner arm 110′″ and the outer arm 112′″ and/orcollar 114′″ may be made of dielectric materials that are not goodconductors of electricity. According to various embodiments, dedicatedelectrodes 1702, 1704 may be omitted, with other components of the endeffector 100′″ serving as electrodes. For example, the collar 114′″and/or outer arm 112′″ may serve as one electrode while the inner arm110′″ may serve as a second electrode. In these embodiments, the innerarm 110′″ and the outer arm 112′″ and/or collar 114′″ may beelectrically isolated from one another. Although the end effector 100′″is illustrated as a wire-operated collar assembly 104′″, it will beappreciated that other embodiments may be transitioned between thedeployed and un-deployed positions similar to end effector 100 describedabove.

In various embodiments, surgical instruments utilizing variousembodiments of the end effectors 100 100′ may be employed in conjunctionwith a flexible endoscope, such as a GIF-100 model available fromOlympus Corporation, for example. In at least one such embodiment, theendoscope, a laparoscope, or a thoracoscope, for example, may beintroduced into the patient trans-anally through the colon, the abdomenvia an incision or keyhole and a trocar, or trans-orally through theesophagus, for example. These devices may assist the surgeon to guideand position the electrical ablation system near the tissue treatmentregion to treat diseased tissue on organs such as the liver, forexample. In another embodiment, these devices may be positioned to treatdiseased tissue near the gastrointestinal (GI) tract, esophagus, and/orlung, for example. In various embodiments, the endoscope may comprise aflexible shaft where the distal end of the flexible shaft may comprise alight source, a viewing port, and at least one working channel. In atleast one such embodiment, the viewing port may transmit an image withinits field of view to an optical device such as a charge coupled device(CCD) camera within the endoscope, for example, so that an operator mayview the image on a display monitor (not shown).

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a clinician manipulating an end of aninstrument extending from the clinician to a surgical site (e.g.,through a trocar, through a natural orifice, through an open surgicalsite, etc.). The term “proximal” refers to the portion closest to theclinician, and the term “distal” refers to the portion located away fromthe surgeon. It will be further appreciated that for conciseness andclarity, spatial terms such as “vertical,” “horizontal,” “up,” and“down” may be used herein with respect to the drawings. However,surgical instruments are used in many orientations and positions, andthese terms are not intended to be limiting and absolute.

While several embodiments have been illustrated and described, and whileseveral illustrative embodiments have been described in considerabledetail, the embodiments are not intended to restrict or in any way limitthe scope of the appended claims to such detail. Additional advantagesand modifications may readily appear to those skilled in the art. Thoseof ordinary skill in the art will readily appreciate the differentadvantages provided by these various embodiments.

While several embodiments have been described, it should be apparent,however, that various modifications, alterations and adaptations tothose embodiments may occur to persons skilled in the art with theattainment of some or all of the advantages of the embodiments. Forexample, according to various embodiments, a single component may bereplaced by multiple components, and multiple components may be replacedby a single component, to perform a given function or functions. Thisapplication is therefore intended to cover all such modifications,alterations and adaptations without departing from the scope of theappended claims.

The devices disclosed herein may be designed to be disposed of after asingle use, or they may be designed to be used multiple times. In eithercase, however, the device may be reconditioned for reuse after at leastone use. Reconditioning may include a combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicemay be disassembled, and any number of particular pieces or parts of thedevice may be selectively replaced or removed in any combination. Uponcleaning and/or replacement of particular parts, the device may bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Those ofordinary skill in the art will appreciate that the reconditioning of adevice may utilize a variety of different techniques for disassembly,cleaning/replacement, and reassembly. Use of such techniques, and theresulting reconditioned device, are all within the scope of the presentapplication.

Preferably, the embodiments described herein will be processed beforesurgery. First a new or used instrument is obtained and, if necessary,cleaned. The instrument may then be sterilized. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK® bag. The container and instrument are thenplaced in a field of radiation that may penetrate the container, such asgamma radiation, x-rays, or higher energy electrons. The radiation killsbacteria on the instrument and in the container. The sterilizedinstrument may then be stored in the sterile container. The sealedcontainer keeps the instrument sterile until it is opened in the medicalfacility.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdo not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

The embodiments are not to be construed as limited to the particularembodiments disclosed. The embodiments are therefore to be regarded asillustrative rather than restrictive. Variations and changes may be madeby others without departing from the scope of the claims. Accordingly,it is expressly intended that all such equivalents, variations andchanges that fall within the scope of the claims be embraced thereby.

In summary, numerous benefits have been described which result fromemploying the concepts described herein. The foregoing description ofthe one or more embodiments has been presented for purposes ofillustration and description. It is not intended to be exhaustive orlimiting to the precise form disclosed. Modifications or variations arepossible in light of the above teachings. The one or more embodimentswere chosen and described in order to illustrate principles andpractical applications to thereby enable one of ordinary skill in theart to utilize the various embodiments and with various modifications asare suited to the particular use contemplated. It is intended that theclaims submitted herewith define the overall scope.

1. A surgical device comprising: an outer sheath, a collar assemblycoupled to the outer sheath, wherein the collar assembly comprises: afirst arm coupled to the outer sheath at a first hinge; a second armcoupled to the first arm at a second hinge; and a collar coupled to thesecond arm; and wherein the collar assembly is movable from anun-deployed position where the first arm and the second arm extend thecollar distally from the outer sheath to a deployed position where thecollar is aligned with the first channel of the outer sheath, andwherein a distal cross section of the collar assembly is smaller whenthe collar assembly is in the deployed position than when the collarassembly is in the un-deployed position.
 2. The surgical device of claim1, wherein the first arm, the second arm, and the collar are positionedsubstantially within a cross-sectional area of a distal end of the outersheath when the collar assembly is in the un-deployed position.
 3. Thesurgical device of claim 1, wherein the collar assembly furthercomprises a spring rod extending from the first arm to at least one ofthe second arm and the collar, wherein the spring rod biases the collarassembly to the deployed position.
 4. The surgical device of claim 1,wherein the collar assembly further comprises a spring rod extendingfrom the first arm to at least one of the second arm and the collar,wherein the spring rod biases the collar assembly to the un-deployedposition.
 5. The surgical device of claim 4, wherein the collar assemblyfurther comprises a wire extending proximally from at least one of thesecond arm and the collar through the outer sheath, wherein the wire isconfigured to transmit a proximally directed force to at least one ofthe second arm and the collar to move the collar assembly to thedeployed position.
 6. The surgical device of claim 1, further comprisinga suturing applicator distally extendable from a first channel of theouter sheath;
 7. The surgical device of claim 6, wherein the suturingapplicator is a needle.
 8. The surgical device of claim 7, wherein thecollar comprises a cap preventing the suturing needle from extendingthrough the cap when the collar assembly is in the deployed position. 9.The surgical device of claim 1, wherein the collar comprises a hollowcenter aligned with the first channel of the outer sheath and positionedto receive at least a portion of the suturing applicator.
 10. Thesurgical device of claim 1, wherein the collar comprises a cap on adistally oriented side of the hollow center.
 11. The surgical device ofclaim 1, further comprising a first electrode and a second electrode.12. The surgical device of claim 11, wherein the first electrode and thesecond electrode are positioned opposite one another when the collarassembly is in the deployed position.
 13. The surgical device of claim11, wherein the first electrode is positioned on the collar and whereinthe second electrode is positioned on the first arm.
 14. The surgicaldevice of claim 11, wherein the collar assembly is the first electrodeand the first arm is the second electrode.
 15. A method of using asurgical device comprising an outer sheath; a suturing needle distallyextendable from a first channel of the outer sheath; and a collarassembly coupled to the outer sheath, wherein the collar assemblycomprises: a first arm coupled to the outer sheath at a first hinge; asecond arm coupled to the first arm at a second hinge; and a collarcoupled to the second arm; and wherein the collar assembly is movablefrom an un-deployed position where the first arm and the second armextend the collar distally from the outer sheath to a deployed positionwhere the collar is aligned with the first channel of the outer sheath,and wherein a distal cross section of the collar assembly is smallerwhen the collar assembly is in the deployed position than when thecollar assembly is in the un-deployed position, the method comprising:extending the collar and at least a portion of the second arm through anopening in a tissue; positioning the collar assembly in the deployedposition such that the outer sheath is on a first side of the tissue andthe collar is on a second side of the tissue; and extending the suturingneedle distally through the tissue.
 16. The method of claim 15, furthercomprising extending the surgical device through a working channel of anendoscope with the collar assembly in the un-deployed position.
 17. Themethod of claim 15, wherein the surgical device comprises: a spring rodextending from the first arm to at least one of the second arm and thecollar, wherein the spring rod biases the collar assembly to theun-deployed position; and a wire extending proximally from at least oneof the second arm and the collar through the outer sheath, wherein thewire is configured to transmit a proximally directed force to at leastone of the second arm and the collar to move the collar assembly to thedeployed position; and wherein positioning the collar to the deployedposition comprises retracting the wire proximally.
 18. The method ofclaim 15, further comprising extending the suturing needle distallythrough at least a portion of a cavity of the collar.
 19. The method ofclaim 18, further comprising: extending the suturing needle distallycompletely through the cavity of the collar; deploying a suture anchorfrom a distal end of the suturing needle; and pulling the suture anchorproximally with the collar.
 20. The method of claim 15, furthercomprising inserting the surgical device into an endoscope workingchannel.
 21. A method of using a surgical device comprising an outersheath; a suturing needle distally extendable from a first channel ofthe outer sheath; and a collar assembly coupled to the outer sheath,wherein the collar assembly comprises: a first arm coupled to the outersheath at a first hinge; a second arm coupled to the first arm at asecond hinge; and a collar coupled to the second arm; and wherein thecollar assembly is movable from an un-deployed position where the firstarm and the second arm extend the collar distally from the outer sheathto a deployed position where the collar is aligned with the firstchannel of the outer sheath, and wherein a distal cross section of thecollar assembly is smaller when the collar assembly is in the deployedposition than when the collar assembly is in the un-deployed position,the method comprising: placing a portion of tissue between the collarand the outer sheath; and extending the suturing needle distally throughthe tissue.
 22. The method of claim 21, wherein the surgical devicecomprises: a spring rod extending from the first arm to at least one ofthe second arm and the collar, wherein the spring rod biases the collarassembly to the un-deployed position; and a wire extending proximallyfrom at least one of the second arm and the collar through the outersheath, wherein the wire is configured to transmit a proximally directedforce to at least one of the second arm and the collar to move thecollar assembly to the deployed position; and wherein the method furthercomprises exerting a proximally directed force on the wire to clamp theportion of tissue between the collar and the outer sheath.
 23. Themethod of claim 21, wherein the portion of tissue defines an opening,and wherein placing the portion of tissue between the collar and theouter sheath comprises closing the opening between the collar and theouter sheath.
 24. The method of claim 21, further comprising extendingthe suturing needle distally through at least a portion of a cavity ofthe collar.
 25. The method of claim 24, further comprising: extendingthe suturing needle distally completely through the cavity of thecollar; deploying a suture anchor from a distal end of the suturingneedle; and pulling the suture anchor proximally with the collar. 26.The method of claim 21, further comprising inserting the surgical deviceinto an endoscope working channel.